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HEALTH AND SAFETY CODE TITLE 2. HEALTH SUBTITLE B. HEALTH PROGRAMS CHAPTER 33. PHENYLKETONURIA, OTHER HERITABLE DISEASES, HYPOTHYROIDISM, AND CERTAIN OTHER DISORDERS SUBCHAPTER A. GENERAL PROVISIONS Sec. 33.001. DEFINITIONS. In this chapter: (1) "Birthing facility" means an inpatient or ambulatory health care facility that offers obstetrical or newborn care services. The term includes: (A) a hospital licensed under Chapter 241 that offers obstetrical services; (B) a birthing center licensed under Chapter 244; (C) a children's hospital; or (D) a facility that provides obstetrical services and is maintained and operated by this state or an agency of this state. (1-a) "Critical congenital heart disease" means an abnormality in the structure or function of the heart that exists at birth, causes severe, life-threatening symptoms, and requires medical intervention within the first few hours, days, or months of life. (1-b) "Heritable disease" means an inherited disease Page -1 -

· Web viewTITLE 2. HEALTH SUBTITLE B. HEALTH PROGRAMS CHAPTER 33. PHENYLKETONURIA, OTHER HERITABLE DISEASES, HYPOTHYROIDISM, AND CERTAIN OTHER DISORDERS SUBCHAPTER A. GENERAL PROVISIONS

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HEALTH AND SAFETY CODE

TITLE 2. HEALTH

SUBTITLE B. HEALTH PROGRAMS

CHAPTER 33. PHENYLKETONURIA, OTHER HERITABLE DISEASES,

HYPOTHYROIDISM, AND CERTAIN OTHER DISORDERS

SUBCHAPTER A. GENERAL PROVISIONS

Sec. 33.001.  DEFINITIONS. In this chapter:

(1)  "Birthing facility" means an inpatient or

ambulatory health care facility that offers obstetrical or

newborn care services.  The term includes:

(A)  a hospital licensed under Chapter 241 that

offers obstetrical services;

(B)  a birthing center licensed under Chapter 244;

(C)  a children's hospital; or

(D)  a facility that provides obstetrical services

and is maintained and operated by this state or an agency of this

state.

(1-a)  "Critical congenital heart disease" means an

abnormality in the structure or function of the heart that exists

at birth, causes severe, life-threatening symptoms, and requires

medical intervention within the first few hours, days, or months

of life.

(1-b)  "Heritable disease" means an inherited disease

that may result in mental or physical retardation or death.

(2)  "Hypothyroidism" means a condition that may cause

severe mental retardation if not treated.

(3)  "Other benefit" means a benefit, other than a

benefit under this chapter, to which an individual is entitled

Page -1 -

for the payment of the costs of services.  The term includes:

(A)  benefits available under:

(i)  an insurance policy, group health plan,

or prepaid medical care plan;

(ii)  Title XVIII of the Social Security Act

(42 U.S.C. Section 1395 et seq.);

(iii)  Title XIX of the Social Security Act

(42 U.S.C. Section 1396 et seq.);

(iv)  the United States Department of

Veterans Affairs;

(v)  the TRICARE program of the United States

Department of Defense; or

(vi)  workers' compensation or any other

compulsory employers insurance program;

(B)  a public program created by federal or state

law or by ordinance or rule of a municipality or political

subdivision of the state, except those benefits created by the

establishment of a municipal or county hospital, a joint

municipal-county hospital, a county hospital authority, a

hospital district, or by the facilities of a publicly supported

medical school; and

(C)  benefits resulting from a cause of action for

health care expenses, or a settlement or judgment based on the

cause of action, if the expenses are related to the need for

services provided under this chapter.

(4)  "Phenylketonuria" means an inherited condition

that may cause severe mental retardation if not treated.

(5)  "Screening test" means a rapid analytical

procedure to determine the need for further diagnostic

evaluation.

Page -2 -

Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 8, eff. Sept. 1,

1991.

Amended by:

Acts 2013, 83rd Leg., R.S., Ch. 268 (H.B. 740), Sec. 2, eff.

September 1, 2013.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0098,

eff. April 2, 2015.

Sec. 33.002.  DETECTION AND TREATMENT PROGRAM ESTABLISHED.

(a) The department shall carry out a program to combat

morbidity, including mental retardation, and mortality in persons

who have phenylketonuria, other heritable diseases, or

hypothyroidism.

(b)  The executive commissioner shall adopt rules necessary

to carry out the program, including a rule specifying other

heritable diseases covered by this chapter.

(c)  The department shall establish and maintain a

laboratory to:

(1)  conduct experiments, projects, and other

activities necessary to develop screening or diagnostic tests for

the early detection of phenylketonuria, other heritable diseases,

and hypothyroidism;

(2)  develop ways and means or discover methods to be

used to prevent or treat phenylketonuria, other heritable

diseases, and hypothyroidism; and

(3)  serve other purposes considered necessary by the

department to carry out the program.

Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 8, eff. Sept. 1,

1991.

Amended by:

Page -3 -

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0099,

eff. April 2, 2015.

Sec. 33.0021.  SICKLE-CELL TRAIT. Notwithstanding any

provision of this chapter, the department shall include sickle-

cell trait in the detection and treatment program established

under this chapter, in the screening for heritable diseases

conducted under Subchapter B, and in the newborn screening

services provided under Subchapter C.

Added by Acts 2009, 81st Leg., R.S., Ch. 179 (H.B. 1672), Sec. 1,

eff. May 27, 2009.

Sec. 33.003.  COOPERATION OF HEALTH CARE PROVIDERS AND

GOVERNMENTAL ENTITIES. (a) The department may invite all

physicians, hospitals, and other health care providers in the

state that provide maternity and newborn infant care to cooperate

and participate in any program established by the department

under this chapter.

(b)  Other boards, agencies, departments, and political

subdivisions of the state capable of assisting the department in

carrying out the program may cooperate with the department and

are encouraged to furnish their services and facilities to the

program.

Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 8, eff. Sept. 1,

1991.

Sec. 33.004.  NEWBORN SCREENING PROGRAM; FEES.

(b)  In accordance with rules adopted by the executive

commissioner, the department shall implement a newborn screening

program.

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(c)  In implementing the newborn screening program, the

department shall obtain the use of screening methodologies and

hire the employees necessary to administer newborn screening

under this chapter.

(e)  The department shall periodically review the newborn

screening program to determine the efficacy and cost-

effectiveness of the program and determine whether adjustments to

the program are necessary to protect the health and welfare of

this state's newborns and to maximize the number of newborn

screenings that may be conducted with the funding available for

the screening.

(f)  The executive commissioner by rule may establish the

amounts charged for newborn screening fees, including fees

assessed for follow-up services, tracking confirmatory testing,

and diagnosis.

Added by Acts 2005, 79th Leg., Ch. 940 (H.B. 790), Sec. 2, eff.

September 1, 2005.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0100,

eff. April 2, 2015.

SUBCHAPTER B. NEWBORN SCREENING

Sec. 33.011.  TEST REQUIREMENT. (a)  The physician

attending a newborn child or the person attending the delivery of

a newborn child that is not attended by a physician shall cause

the child to be subjected to screening tests approved by the

department for phenylketonuria, other heritable diseases,

hypothyroidism, and other disorders for which screening is

required by the department.

Page -5 -

(a-1)  Except as provided by this subsection and to the

extent funding is available for the screening, the department

shall require newborn screening tests to screen for disorders

listed as core and secondary conditions in the Recommended

Uniform Screening Panel of the Secretary's Advisory Committee on

Heritable Disorders in Newborns and Children or another report

determined by the department to provide more stringent newborn

screening guidelines to protect the health and welfare of this

state's newborns.  The department, with the advice of the Newborn

Screening Advisory Committee, may require additional newborn

screening tests under this subsection to screen for other

disorders or conditions.  The department may exclude from the

newborn screening tests required under this subsection screenings

for galactose epimerase and galactokinase.

(b)  The department may prescribe the screening test

procedures to be used and the standards of accuracy and precision

required for each test.

(c)  Except as provided by Subsection (d), the screening

tests required by this section must be performed by the

laboratory established by the department or by a laboratory

approved by the department under Section 33.016.

(d)  The department, with the advice of the Newborn

Screening Advisory Committee, shall authorize a screening test

for critical congenital heart disease to be performed at a

birthing facility that provides care to newborn patients and that

complies with the test procedures and the standards of accuracy

and precision required by the department for each screening test.

(e)  If the department under Subsection (d) authorizes the

performance at a birthing facility of a screening test for

critical congenital heart disease, a birthing facility must

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perform the screening test on each newborn who is a patient of

the facility before the newborn is discharged from the facility

unless:

(1)  the parent declines the screening;

(2)  the newborn is transferred to another facility

before the screening test is performed;

(3)  the screening test has previously been completed;

or

(4)  the newborn is discharged from the birthing

facility not more than 10 hours after birth and a referral for

the newborn was made to another birthing facility, physician, or

health care provider.

(f)  Before requiring any additional screening test for

critical congenital heart disease, the department must review the

necessity of the additional screening test, including an

assessment of the test implementation costs to the department,

birthing facilities, and other health care providers.

Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 8, eff. Sept. 1,

1991.

Amended by:

Acts 2005, 79th Leg., Ch. 940 (H.B. 790), Sec. 3, eff.

September 1, 2005.

Acts 2009, 81st Leg., R.S., Ch. 1124 (H.B. 1795), Sec. 2,

eff. September 1, 2009.

Acts 2013, 83rd Leg., R.S., Ch. 268 (H.B. 740), Sec. 3, eff.

September 1, 2013.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0101,

eff. April 2, 2015.

Sec. 33.0111.  DISCLOSURE STATEMENT AND CONSENT. (a)  The

Page -7 -

department shall develop a disclosure statement that clearly

discloses to the parent, managing conservator, or guardian of a

newborn child subjected to screening tests under Section 33.011:

(1)  that the department or a laboratory established or

approved by the department under Section 33.016 may retain for

use by the department or laboratory genetic material used to

conduct the newborn screening tests and discloses how the

material is managed and used subject to this section and Sections

33.0112 and 33.018;

(2)  that reports, records, and information obtained by

the department under this chapter that do not identify a child or

the family of a child will not be released for public health

research purposes under Section 33.018(c-1) unless a parent,

managing conservator, or guardian of the child consents to

disclosure; and

(3)  that newborn screening blood spots and associated

data are confidential under law and may only be used as described

by Section 33.018.

(b)  The disclosure statement required by Subsection (a)

must be included on the form developed by the department to

inform parents about newborn screening.  The disclosure statement

must:

(1)  be in a format that allows a parent, managing

conservator, or guardian of a newborn child to consent to

disclosure under Section 33.018(c-1);

(2)  include instructions on how to complete the

portions of the form described by Subdivision (1);

(3)  include the department's mailing address; and

(4)  describe how a parent, managing conservator, or

guardian of a newborn child may obtain information regarding

Page -8 -

consent through alternative sources.

(c)  At the time a newborn child is subjected to screening

tests under Section 33.011, the physician attending a newborn

child or the person attending the delivery of a newborn child

that is not attended by a physician shall provide the parent,

managing conservator, or guardian of a newborn child a copy of

the written disclosure statement developed by the department

under this section.

(d)  The department shall establish procedures for a

physician attending a newborn child or the person attending the

delivery of a newborn child to provide verification to the

department that the physician or person has provided the parent,

managing conservator, or guardian of the newborn child the

disclosure statement required under this section.

(e)  The physician attending a newborn child or the person

attending the delivery of a newborn child that is not attended by

a physician shall submit any document required by the department.

(f)  This section does not supersede the requirements

imposed by Section 33.018.

(g)  Repealed by Acts 2013, 83rd Leg., R.S., Ch. 268, Sec.

7, eff. September 1, 2013.

(h)  Nothing in this section prohibits a physician attending

a newborn child from delegating the physician's responsibilities

under this section to any qualified and properly trained person

acting under the physician's supervision.

Added by Acts 2009, 81st Leg., R.S., Ch. 179 (H.B. 1672), Sec. 2,

eff. May 27, 2009.

Amended by:

Acts 2011, 82nd Leg., R.S., Ch. 1273 (H.B. 411), Sec. 1,

eff. June 1, 2012.

Page -9 -

Acts 2011, 82nd Leg., R.S., Ch. 1273 (H.B. 411), Sec. 2,

eff. June 1, 2012.

Acts 2013, 83rd Leg., R.S., Ch. 268 (H.B. 740), Sec. 4, eff.

September 1, 2013.

Acts 2013, 83rd Leg., R.S., Ch. 268 (H.B. 740), Sec. 7, eff.

September 1, 2013.

Sec. 33.0112.  DESTRUCTION OF GENETIC MATERIAL. (a)  The

department shall destroy any genetic material obtained from a

child under this chapter not later than the second anniversary of

the date the department receives the genetic material unless a

parent, managing conservator, or guardian of the child consents

to disclosure under Section 33.018(c-1).

(b)  The department shall destroy any genetic material

obtained from a child under this chapter not later than the

second anniversary of the date the department receives the

genetic material if:

(1)  a parent, managing conservator, or guardian of the

child consents to disclosure under Section 33.018(c-1);

(2)  the parent, managing conservator, or guardian who

consented to the disclosure revokes the consent under Section

33.018(i); and

(3)  the department receives the written revocation of

consent under Section 33.018(i) not later than the second

anniversary of the date the department received the genetic

material.

(c)  The department shall destroy any genetic material

obtained from a child under this chapter not later than the 60th

day after the date the department receives a written revocation

of consent under Section 33.018(i) if:

Page -10 -

(1)  a parent, managing conservator, or guardian of the

child consented to disclosure under Section 33.018(c-1);

(2)  the parent, managing conservator, or guardian who

consented to the disclosure or the child revokes the consent

under Section 33.018(i); and

(3)  the department receives the written revocation of

consent later than the second anniversary of the date the

department received the genetic material.

Added by Acts 2009, 81st Leg., R.S., Ch. 179 (H.B. 1672), Sec. 2,

eff. May 27, 2009.

Amended by:

Acts 2011, 82nd Leg., R.S., Ch. 1273 (H.B. 411), Sec. 3,

eff. June 1, 2012.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0102,

eff. April 2, 2015.

Sec. 33.012.  EXEMPTION. (a) Screening tests may not be

administered to a newborn child whose parents, managing

conservator, or guardian objects on the ground that the tests

conflict with the religious tenets or practices of an organized

church of which they are adherents.

(b)  If a parent, managing conservator, or guardian objects

to the screening tests, the physician or the person attending the

newborn child that is not attended by a physician shall ensure

that the objection of the parent, managing conservator, or

guardian is entered into the medical record of the child. The

parent, managing conservator, or guardian shall sign the entry.

Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 8, eff. Sept. 1,

1991.

Page -11 -

Sec. 33.013.  LIMITATION ON LIABILITY. A physician,

technician, or other person administering the screening tests

required by this chapter is not liable or responsible because of

the failure or refusal of a parent, managing conservator, or

guardian to consent to the tests for which this chapter provides.

Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 8, eff. Sept. 1,

1991.

Sec. 33.014.  DIAGNOSIS; FOLLOW-UP. (a) If, because of an

analysis of a specimen submitted under Section 33.011, the

department reasonably suspects that a newborn child may have

phenylketonuria, another heritable disease, hypothyroidism, or

another disorder for which the screening tests are required, the

department shall notify the person who submits the specimen that

the results are abnormal and provide the test results to that

person.  The department may notify one or more of the following

that the results of the analysis are abnormal and recommend

further testing when necessary:

(1)  the physician attending the newborn child or the

physician's designee;

(2)  the person attending the delivery of the newborn

child that was not attended by a physician;

(3)  the parents of the newborn child;

(4)  the health authority of the jurisdiction in which

the newborn child was born or in which the child resides, if

known;  or

(5)  physicians who are cooperating pediatric

specialists for the program.

(b)  If a screening test indicates that a newborn child is

at high risk, the department shall recommend that the child be

Page -12 -

placed under the medical care of a licensed physician for

diagnosis and provide the name of a consultant pediatric

specialist in the child's geographic area.

(c)  The department, the health authority, and the

consulting pediatric specialist may follow up a positive test

with the attending physician or with a parent of the newborn

child if the child was not attended by a physician at birth.

Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 8, eff. Sept. 1,

1991.

Amended by:

Acts 2005, 79th Leg., Ch. 940 (H.B. 790), Sec. 4, eff.

September 1, 2005.

Sec. 33.015.  REPORTS; RECORD KEEPING. (a)  Each

physician, health authority, birthing facility, or other

individual who has the information of a confirmed case of a

disorder for which a screening test is required that has been

detected by a mechanism other than identification through a

screening of a specimen by the department's diagnostic laboratory

shall report the confirmed case to the department.

(b)  The department may collect data to derive incidence and

prevalence rates of disorders covered by this chapter from the

information on the specimen form submitted to the department for

screening determinations.

(c)  The department shall maintain a roster of children born

in this state who have been diagnosed as having one of the

disorders for which the screening tests are required.

(d)  The department may cooperate with other states in the

development of a national roster of individuals who have been

diagnosed as having one of the disorders for which the screening

Page -13 -

tests are required if:

(1)  participation in the national roster encourages

systematic follow-up in the participating states;

(2)  incidence and prevalence information is made

available to participating newborn screening programs in other

states; and

(3)  each participating newborn screening program

subscribes to an agreement to protect the identity and diagnosis

of the individuals whose names are included in the national

roster.

Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 8, eff. Sept. 1,

1991.

Amended by:

Acts 2013, 83rd Leg., R.S., Ch. 268 (H.B. 740), Sec. 5, eff.

September 1, 2013.

Sec. 33.016.  APPROVAL OF LABORATORIES. (a)  The department

may develop a program to approve any laboratory that wishes to

perform the tests required to be administered under this

chapter.  To the extent that they are not otherwise provided in

this chapter, the executive commissioner may adopt rules

prescribing procedures and standards for the conduct of the

program.

(b)  The department may prescribe the form and reasonable

requirements for the application and the procedures for

processing the application.

(c)  The department may prescribe the test procedure to be

employed and the standards of accuracy and precision required for

each test.

(d)  The department may extend or renew any approval in

Page -14 -

accordance with reasonable procedures prescribed by the executive

commissioner.

(e)  The department may for good cause, after notice to the

affected laboratory and a hearing if requested, restrict,

suspend, or revoke any approval granted under this section.

(f)  Hearings under this section shall be conducted in

accordance with the department's hearing rules and the applicable

provisions of Chapter 2001, Government Code.

Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 8, eff. Sept. 1,

1991; Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), eff. Sept. 1,

1995.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0103,

eff. April 2, 2015.

Sec. 33.0165.  MUTUAL AID AGREEMENT FOR NEWBORN SCREENING

LABORATORY SERVICES. (a)  In this section, "newborn screening

laboratory services" means the performance of tests to analyze

specimens collected as part of the newborn screenings performed

under this subchapter.

(b)  Notwithstanding Section 12.0122 or other law, the

department may enter into a mutual aid agreement to provide

newborn screening laboratory services to another state and to

receive newborn screening laboratory services from another state

in the event of an unexpected interruption of service, including

an interruption caused by a disaster.

(c)  Each mutual aid agreement under Subsection (b) shall

include provisions:

(1)  to address the confidentiality of the identity of

the newborn child and the newborn child's family; and

Page -15 -

(2)  to ensure the return of blood specimens and

related records to the state that received the newborn screening

laboratory services.

Added by Acts 2009, 81st Leg., R.S., Ch. 109 (H.B. 1671), Sec. 1,

eff. September 1, 2009.

Transferred, redesignated and amended from Health and Safety

Code, Section 12.01221 by Acts 2015, 84th Leg., R.S., Ch. 1 (S.B.

219), Sec. 3.0015, eff. April 2, 2015.

Sec. 33.017.  NEWBORN SCREENING ADVISORY COMMITTEE. (a)

The department shall establish the Newborn Screening Advisory

Committee.

(b)  The advisory committee consists of members appointed by

the commissioner.  The advisory committee must include the

following members:

(1)  at least four physicians licensed to practice

medicine in this state, including at least two physicians

specializing in neonatal-perinatal medicine;

(2)  at least two hospital representatives;

(3)  at least two persons who have family members

affected by a condition for which newborn screening is or may be

required under this subchapter; and

(4)  at least two health care providers who are

involved in the delivery of newborn screening services, follow-

up, or treatment in this state.

(c)  The advisory committee shall:

(1)  advise the department regarding strategic

planning, policy, rules, and services related to newborn

screening and additional newborn screening tests for each

disorder included in the list described by Section 33.011(a-1);

Page -16 -

and

(2)  review the necessity of requiring additional

screening tests, including an assessment of the test

implementation costs to the department, birthing facilities, and

other health care providers.

(d)  The advisory committee shall adopt bylaws governing the

committee's operations.

(e)  The advisory committee may appoint subcommittees.

(f)  The advisory committee shall meet at least three times

each year and at other times at the call of the commissioner.

(g)  A member of the advisory committee is not entitled to

compensation, but is entitled to reimbursement for travel or

other expenses incurred by the member while conducting the

business of the advisory committee, as provided by the General

Appropriations Act.

(h)  The advisory committee is not subject to Chapter 2110,

Government Code.

Added by Acts 2009, 81st Leg., R.S., Ch. 1124 (H.B. 1795), Sec.

3, eff. September 1, 2009.

Amended by:

Acts 2013, 83rd Leg., R.S., Ch. 268 (H.B. 740), Sec. 6, eff.

September 1, 2013.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0104,

eff. April 2, 2015.

Sec. 33.018.  CONFIDENTIALITY. (a)  In this section:

(1)  "Affiliated with a health agency" means a person

who is an employee or former employee of a health agency.

(2)  Repealed by Acts 2015, 84th Leg., R.S., Ch. 1,

Sec. 3.1639(16), eff. April 2, 2015.

Page -17 -

(3)  Repealed by Acts 2015, 84th Leg., R.S., Ch. 1,

Sec. 3.1639(16), eff. April 2, 2015.

(4)  "Health agency" means the commission and the

health and human services agencies listed in Section 531.001,

Government Code.

(5)  "Public health purpose" means a purpose that

relates to cancer, a birth defect, an infectious disease, a

chronic disease, environmental exposure, or newborn screening.

(a-1)  Reports, records, and information obtained or

developed by the department under this chapter are confidential

and are not subject to disclosure under Chapter 552, Government

Code, are not subject to subpoena, and may not otherwise be

released or made public except as provided by this section.

(b)  Notwithstanding other law, reports, records, and

information obtained or developed by the department under this

chapter may be disclosed:

(1)  for purposes of diagnosis or follow-up authorized

under Section 33.014;

(2)  with the consent of each identified individual or

an individual authorized to consent on behalf of an identified

child;

(3)  as authorized by court order;

(4)  to a medical examiner authorized to conduct an

autopsy on a child or an inquest on the death of a child;

(5)  to public health programs of the department for

public health research purposes, provided that the disclosure is

approved by:

(A)  the commissioner or the commissioner's

designee; and

(B)  an institutional review board or privacy

Page -18 -

board of the department as authorized by the federal privacy

requirements adopted under the Health Insurance Portability and

Accountability Act of 1996 (Pub. L. No. 104-191) contained in 45

C.F.R. Part 160 and 45 C.F.R. Part 164, Subparts A and E;

(6)  for purposes relating to review or quality

assurance of the department's newborn screening under this

chapter or the department's newborn screening program services

under Subchapter C, provided that no disclosure occurs outside of

the department's newborn screening program;

(7)  for purposes related to obtaining or maintaining

federal certification, including related quality assurance, for

the department's laboratory, provided that no disclosure occurs

outside of the department's newborn screening program; or

(8)  for purposes relating to improvement of the

department's newborn screening under this chapter or the

department's newborn screening program services under Subchapter

C, provided that the disclosure is approved by the commissioner

or the commissioner's designee.

(c)  Notwithstanding other law, reports, records, and

information that do not identify a child or the family of a child

may be released without consent if the disclosure is for:

(1)  statistical purposes;

(2)  purposes related to obtaining or maintaining

federal certification, including related review and quality

assurance:

(A)  for the department's laboratory that require

disclosure outside of the department's newborn screening program;

or

(B)  for a public or private laboratory to perform

newborn screening tests that are not part of inter-laboratory

Page -19 -

exchanges required for federal certification of the department's

laboratory, provided that the disclosure is approved by the

commissioner or the commissioner's designee; or

(3)  other  quality assurance purposes related to

public health testing equipment and supplies, provided that the

disclosure is approved by:

(A)  the commissioner or the commissioner's

designee; and

(B)  an institutional review board or privacy

board of the department.

(c-1)  Notwithstanding other law, reports, records, and

information that do not identify a child or the family of a child

may be released for public health research purposes not described

by Subsection (b)(5) if:

(1)  a parent, managing conservator, or guardian of the

child consents to the disclosure; and

(2)  the disclosure is approved by:

(A)  an institutional review board or privacy

board of the department; and

(B)  the commissioner or the commissioner's

designee.

(d)  A state officer or employee, a department contractor,

or a department contractor's employee, officer, director, or

subcontractor may not be examined in a civil, criminal, special,

or other judicial or administrative proceeding as to the

existence or contents of records, reports, or information made

confidential by this section unless disclosure is authorized by

this section.

(e)  If disclosure is approved by the commissioner or the

commissioner's designee under Subsection (c)(3) or (c-1), the

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department shall post notice on the newborn screening web page on

the department's Internet website that disclosure has been

approved.  The commissioner shall determine the form and content

of the notice.

(f)  In accordance with this section, the commissioner or

the commissioner's designee:

(1)  may approve disclosure of reports, records, or

information obtained or developed under this chapter only for a

public health purpose; and

(2)  may not approve disclosure of reports, records, or

information obtained or developed under this chapter for purposes

related to forensic science or health insurance underwriting.

(g)  An institutional review board or privacy board of the

department that reviews a potential disclosure under this section

must include at least three persons who are not affiliated with a

health agency, one of whom must be a member of the public.

(h)  Nothing in this section affects the requirement that

screening tests be performed under Section 33.011.

(i)  If a parent, managing conservator, or guardian of a

child consents to disclosure under this section:

(1)  the parent, managing conservator, or guardian who

consented to the disclosure may revoke the consent, in writing,

at any time by using a form designated by the department; and

(2)  the child may revoke the consent, in writing, at

any time on or after the date the child attains the age of

majority by using a form designated by the department.

(j)  If a person revokes consent under Subsection (i), the

department shall destroy any genetic material obtained from the

child as provided by Section 33.0112.

Added by Acts 2009, 81st Leg., R.S., Ch. 179 (H.B. 1672), Sec. 3,

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eff. May 27, 2009.

Redesignated from Health and Safety Code, Section 33.017 by Acts

2011, 82nd Leg., R.S., Ch. 91 (S.B. 1303), Sec. 27.001(24), eff.

September 1, 2011.

Amended by:

Acts 2011, 82nd Leg., R.S., Ch. 1273 (H.B. 411), Sec. 4,

eff. June 1, 2012.

Acts 2011, 82nd Leg., R.S., Ch. 1273 (H.B. 411), Sec. 4,

eff. June 17, 2011.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec.

3.1639(16), eff. April 2, 2015.

SUBCHAPTER C. NEWBORN SCREENING PROGRAM SERVICES

Sec. 33.031.  COORDINATION WITH CHILDREN WITH SPECIAL HEALTH

CARE NEEDS SERVICES. (a) All newborn children and other

individuals under 21 years of age who have been screened, have

been found to be presumptively positive through the newborn

screening program for phenylketonuria, other heritable diseases,

hypothyroidism, or another disorder for which the screening tests

are required, and may be financially eligible may be referred to

the department's services program for children with special

health care needs.

(b)  An individual who is determined to be eligible for

services under the services program for children with special

health care needs shall be given approved services through that

program. An individual who does not meet that eligibility

criteria shall be referred to the newborn screening program for a

determination of eligibility for newborn screening program

services.

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Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 8, eff. Sept. 1,

1991; Acts 1999, 76th Leg., ch. 1505, Sec. 3.11, eff. Sept. 1,

1999.

Amended by:

Acts 2005, 79th Leg., Ch. 940 (H.B. 790), Sec. 5, eff.

September 1, 2005.

Sec. 33.032.  PROGRAM SERVICES. (a)  Within the limits of

funds available for this purpose and in cooperation with the

individual's physician, the department may provide services

directly or through approved providers to individuals of any age

who meet the eligibility criteria specified by department rules

on the confirmation of a positive test for phenylketonuria, other

heritable diseases, hypothyroidism, or another disorder for which

the screening tests are required.

(b)  The executive commissioner may adopt:

(1)  rules specifying the type, amount, and duration of

program services to be offered;

(2)  rules establishing the criteria for eligibility

for services, including the medical and financial criteria;

(3)  rules establishing the procedures necessary to

determine the medical, financial, and other eligibility of the

individual;

(4)  substantive and procedural rules for applying for

program services and processing those applications;

(5)  rules for providing services according to a

sliding scale of financial eligibility;

(6)  substantive and procedural rules for the denial,

modification, suspension, and revocation of an individual's

approval to receive services; and

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(7)  substantive and procedural rules for the approval

of providers to furnish program services.

(c)  The department may select providers according to the

criteria in the department's rules.

(d)  The executive commissioner by rule may establish fees

to be collected by the department for the provision of services,

except that services may not be denied to an individual because

of the individual's inability to pay the fees.

Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 8, eff. Sept. 1,

1991.

Amended by:

Acts 2005, 79th Leg., Ch. 940 (H.B. 790), Sec. 6, eff.

September 1, 2005.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0105,

eff. April 2, 2015.

Sec. 33.033.  CONSENT. The department may not provide

services without the consent of the individual or, if the

individual is a minor, the minor's parent, managing conservator,

or guardian.

Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 8, eff. Sept. 1,

1991.

Sec. 33.034.  DENIAL, MODIFICATION, SUSPENSION, AND

REVOCATION OF APPROVAL TO PROVIDE SERVICES. (a) After notice

and an opportunity for a fair hearing, the department may deny

the approval or modify, suspend, or revoke the approval of a

person to provide services under this chapter.

(b)  Notice shall be given and the hearing shall be

conducted in accordance with the department's informal hearing

Page -24 -

procedures.

(c)  Chapter 2001, Government Code, does not apply to the

notice and hearing required by this section.

Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 8, eff. Sept. 1,

1991; Acts 1995, 74th Leg., ch. 76, Sec. 5.95(66), eff. Sept. 1,

1995.

Amended by:

Acts 2005, 79th Leg., Ch. 728 (H.B. 2018), Sec. 9.001, eff.

September 1, 2005.

Sec. 33.035.  INDIVIDUALS ELIGIBLE FOR SERVICES. (a) An

individual is not eligible to receive the services authorized by

this chapter at no cost or reduced cost to the extent that the

individual or the parent, managing conservator, guardian, or

other person with a legal obligation to support the individual is

eligible for some other benefit that would pay for all or part of

the services.

(b)  The department may waive ineligibility under Subsection

(a) if the department finds that:

(1)  good cause for the waiver is shown; and

(2)  enforcement of the requirement would tend to

defeat the purpose of this chapter or disrupt the administration

or prevent the provision of services to an otherwise eligible

recipient.

(c)  When an application for services is filed or at any

time that an individual is eligible for or receiving services,

the applicant or recipient shall inform the department of any

other benefit to which the applicant, recipient, or person with a

legal obligation to support the applicant or recipient may be

entitled.

Page -25 -

(d)  The executive commissioner by rule shall provide

criteria for actions taken under this section.

Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 8, eff. Sept. 1,

1991.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0106,

eff. April 2, 2015.

Sec. 33.036.  DENIAL, MODIFICATION, SUSPENSION, AND

REVOCATION OF ELIGIBILITY TO RECEIVE SERVICES. (a) After notice

to the individual or, if the individual is a minor, the

individual's parent, managing conservator, or guardian and an

opportunity for a fair hearing, the department may deny, modify,

suspend, or revoke the determination of a person's eligibility to

receive services at no cost or at reduced cost under this

chapter.

(b)  Notice shall be given and the hearing shall be

conducted in accordance with the department's informal hearing

procedures.

(c)  Chapter 2001, Government Code, does not apply to the

notice and hearing required by this section.

Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 8, eff. Sept. 1,

1991; Acts 1995, 74th Leg., ch. 76, Sec. 5.95(66), eff. Sept. 1,

1995.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0107,

eff. April 2, 2015.

Sec. 33.037.  REIMBURSEMENT. (a)  The department may

require an individual or, if the individual is a minor, the

Page -26 -

minor's parent, managing conservator, or guardian, or other

person with a legal obligation to support the individual to pay

or reimburse the department for all or part of the cost of the

services provided.

(b)  The recipient or the parent, managing conservator,

guardian, or other person with a legal obligation to support an

individual who has received services from the department that are

covered by some other benefit shall, when the other benefit is

received, reimburse the department for the cost of services

provided.

Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 8, eff. Sept. 1,

1991.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0108,

eff. April 2, 2015.

Sec. 33.038.  RECOVERY OF COSTS. (a) The department is

entitled to recover an expenditure for services provided under

this chapter from:

(1)  a person who does not reimburse the department as

required by this chapter; or

(2)  a third party with a legal obligation to pay other

benefits and who has received prior written notice of the

department's interests in the other benefits.

(b)  This section creates a separate and distinct cause of

action, and the department may request the attorney general to

bring suit in the appropriate court of Travis County on behalf of

the department.

(c)  In a judgment in favor of the department, the court may

award attorney fees, court costs, and interest accruing from the

Page -27 -

date on which the department provides the service to the date on

which the department is reimbursed.

(d)  The executive commissioner by rule shall provide

criteria for actions taken under this section.

Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 8, eff. Sept. 1,

1991.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0109,

eff. April 2, 2015.

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